(35 days)
Not Found
No
The device description focuses on the material properties and intended uses of silicone elastomer sheeting, with no mention of software, algorithms, or data processing that would indicate the presence of AI or ML.
Yes
The "Intended Use / Indications for Use" section lists various medical applications such as "Nasal Splinting," "wound covering for gastroschisis," "Tympanic Membrane Repair," and "Correction of Strabismus," which are procedures aimed at treating or alleviating medical conditions.
No
The description of the device's intended use and function clearly indicates it is a material for surgical repair, wound covering, and tissue regeneration, not for diagnosing conditions.
No
The device description clearly states it is made from "biocompatible silicone high consistency rubber" and is available in "polyester mesh reinforced and nonreinforced in a variety of thicknesses," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures, wound management, and tissue repair within the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The device is described as a silicone elastomer sheeting used for physical support and covering within the body. This is consistent with a surgical implant or dressing, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information.
The device is clearly intended for therapeutic and supportive purposes within the body, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination.
Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.
Product codes (comma separated list FDA assigned to the subject device)
MIB
Device Description
Duralastic I and II Silicone Elastomer Sheeting is made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 704. Duralastic Sheeting is a peroxide cured rubber of a 45 - 55 Durometer hardness (Shore A). It has an elasticity of 700 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Duralastic I and II are made from HCRA-50, an Applied Silicone dimethylpolysiloxane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal, Gastroschisis, Teeth, Gingival Margin, External Ear Canal, Tympanic Membrane, Tendon, Urethra, Eye (Correction of Strabismus), Head (Galea), Orbital Floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 874.3620 Ear, nose, and throat synthetic polymer material.
(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.
0
6971480
Allied Biomedical Corporation 3850 Ramada Drive Paso Robles, CA 93446
MAY 28 1997
TAB H
510 (K) SUMMARY
PRODUCT DESCRIPTION
Duralastic I and II Silicone Elastomer Sheeting is made from a biocompatible silicone high consistency rubber, HCRP-50 made by Applied Silicone. It is available in polyester mesh reinforced and nonreinforced in a variety of thicknesses. The silicone elastomer used to make this product have met all Biocompatibility Guidelines set for by FDA for the replacement of Dow Corning Products. These biomaterial standards exceed or meet Class VI USP Standards in that they include Teratogenicity, Mutagenicity, Carcinogenicity and Toxicity Testing. These referenced material characterizations are found in Applied Master File - MAF 704
SUBSTANTIAL EQUIVALENCE
Under it's original 510k K955368 and K955370 Duralastic I and II was found to be SE to Applied Biomaterial Technologies Duralastic Sheeting and Dow Corning's Silastic Sheeting in the Premarket Notification for the nonsterile Duralastic Sheeting. Because Duralastic Sheeting is made from Dow Corning Analogs and made in the same sizes and thicknesses for the same intended use it has been found SE to the predicate devices.
INTENDED USES
Duralastic I and II are intended for a variety of medical purposes both in short term and long term applications. For short term application this list includes nasal splinting, wound dressings, scar coverings, temporary use in TMJ disease, temporary joint shims, and laboratory uses. For long term use this list includes nasal septal repair, orbital floor reconstruction, tympanic membrane repair, dialysis shunt anchoring, duramater repair, staged repair of omphalocoel, lengthening of extraocular muscles, tendon and nerve anastomosis, facilitation of osteogenesis or guided tissue regeneration, and other uses deemed appropriate by the using surgeon. Silicone sheeting has been in use for over 30 years and the uses are myriad. Allied Biomedical advises surgeons to consult the literature before utilizing Duralastic Sheeting for any purpose in the package inserts.
PHYSICAL AND CHEMICAL PROPERTIES
Duralastic Sheeting is a peroxide cured rubber of a 45 - 55
1
510(k) Summary page 2. TAB H
Durometer hardness (Shore A). It has an elasticity of 700 percent with a tensile strength of 1600 psi and a tear strength of 190 psi (Tear Die C). The elasticity is greatly reduced in the polyester reinforced sheets. The specific gravity is 1.16. Chemically Duralastic I and II are made from HCRA-50, an Applied Silicone dimethylpolysiloxane. For details on the foregoing chemical and physical properties consult Masterfile MAF 704
机 ::
STERILIZATION CYCLE
Duralastic I and II sheeting are sterilized via gamma radiation 2.5 - 4.2 Megarads. The validation of this cycle was performed by STI Corporation of Brea California. STI uses Sterigenics Inc. as the contract gamma radiation sterilizer. The validation uses Method 1 Testing as defined in the ANSI/AAMI/ISO 11137-1994 "Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization."
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 1997
Mr. Gerald Hanson Regulatory Affairs Allied Biomedical Corporation .................. 3850 Ramada Drive Paso Robles, California 93446
Re: K971480
Trade Name: Duralastic I and Duralastic II Silicone Sheeting Regulatory Class: Unclassified Product Code: MIB Dated: April 15, 1997 Received: April 23, 1997
Dear Mr. Hanson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (2) CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Gerald Hanson
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page_ 1 _of
Number (if known) : K971480 SI . . . K
Device Name: Duralastic I and Duralastic II Silicone Sheeting
Indications For Use:
Duralastic I (Short Term) Nasal Splinting, Wound Dressings, wound covering for gastroschisis, suture bolsters, drains, Scar Coverings, Laboratory Uses, Temporary facilitation of osteogenesis and guided tissue regeneration between the teeth and gingival margin, or external ear canal for example, temporary joing andrea and other short term uses according to the surgeon's determination.
Chalastic II (Long Term) Nonreinforced - Tympanic Membrane Repair, Pural Covering . 005inch, Nasal Septal Repair, Tendon Anatomobile, na ral repair - 007inch. Correction of Strabismus .010inch, Galea Repair Shunt Anchors . 060inch. Reinforced - Facilitation of Osteogenesis 007 hon, repair of urethral strictures .007inch, Staged Repair of mphalocoel . 020inch, Repair of Orbital Floor Fractures .040inch.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED !
Concurrence of CDRH, Office of Device Evaluation
peralta
(Division Sign-Of)
Division of General Restorative Devigasy 71480
510(k) Number.
Prescription Use
OR
Over - The - Counter Use
(Optional Format 1-2-96)